FDA Related News

Federal Register

Guide on What Constitutes an Inspection Delay/Refusal

Federal Register notice: FDA makes available a draft guidance entitled Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug o...

Animal Drugs

Updated CVM Guide on Antimicrobial Resistance Risks

FDA issues a draft update to guidance for industry #152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological ...

Medical Devices

Providence Medical Tech Cavux Facet Device Cleared

FDA clears a Providence Medical Technology Cavux Facet Fixation System (FFS) for spinal surgery patients requiring a revision for an anterior pseudart...

Human Drugs

Aurigene Ditches Psoriasis Drug Candidate

Dr. Reddys subsidiary Aurigene Oncology halts the development of its psoriasis investigational drug after reporting poor results of a placebo-controll...

Human Drugs

Draft Guide on Pulmonary Tuberculosis Drugs

FDA posts a draft guidance entitled Pulmonary Tuberculosis (TB): Developing Drugs for Treatment.

Draft Inspection Refusal Guidance

FDA publishes a draft guidance defining the types of behaviors that FDA considers to be delaying, denying, or limiting an inspection, or refusing to p...

Biologics

FDA Stem Cell Therapy Regulation at Risk: Attorneys

Three Ropes & Gray attorneys describe the potential for a Circuit Courts of Appeals split over FDA authority in regulating stem cell clinics.

Human Drugs

FDA Updates CRL Guidance Performance Goals

FDA publishes a revised guidance incorporating GDUFA 3 performance goals for complete response letter activities.

Human Drugs

Updated Xeloda Labeling Approved

FDA approves revised labeling for Genentechs Xeloda.

Human Drugs

FDA Extends Lynparza sNDA Review by 3 Months

FDA extends by three months its review of an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) in combination with Janssens Zytiga (abira...